A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

A Observational RWS of YWBC on the Prognosis and Treatment

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.

We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.

All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.

In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300060
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel).

Subgroups were stratified according to different stages, treatment methods and pathological types.

The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.

Description

Inclusion Criteria:

1. Histologically confirmed as breast cancer.
2. The age of diagnosis was 18-35 years old.
3. ECOG score was 0-2, and the expected survival time was more than 3 months.
4. No serious complications; no liver, kidney, hematopoiesis dysfunction.
5. Informed consent, and patients willing to long-term follow-up. -

Exclusion Criteria:

1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
2. Having a clear history of neurological or mental disorders (including epilepsy or dementia).
3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
4. Pregnant or lactating female patients.
5. HIV infected patients.
6. Patients with other tumors.
7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The time from the first medication at the beginning of treatment to the first disease progression or death from any cause	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	time from randomization to death from any cause	5 years
ORR	After treatment, the percentage of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit was evaluated, including complete remission (CR) + partial remission (PR)	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	It refers to any adverse medical event during the clinical study. It is not necessarily a causal relationship with treatment.	5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: prognosis; young women with breast cancer; gene mutation characteristics
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: YWBC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No